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Intratracheal Umbilical Cord-derived Mesenchymal Stem Cells for Severe Bronchopulmonary Dysplasia

NCT ID: NCT01207869

Last Updated: 2010-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-07-31

Brief Summary

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Mesenchymal stem cells (MSCs) have been reported to be effective to prevent alveolar growth arrest in experimental bronchopulmonary dysplasia (BPD). The aim is to treat the extremely premature infant with severe BPD to establish whether intratracheal instillation of umbilical cord-derived MSCs (ucMSCs) is safe and effective as a rescue treatment for severe BPD.

Detailed Description

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Conditions

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Bronchopulmonary Dysplasia Extremely Premature Infants Severe BPD That Conventional Therapies Has Failed No Severe Congenital Anomalies no Severe IVH Neither Cystic PVL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Mesenchymal stem cells

the ucMSCs suspension(3× 106 cells per kg of the patient's weight) will be instilled through a 6 French end-hole catheter inserted into the infant's endotracheal tube

Group Type EXPERIMENTAL

ucMSCs

Intervention Type BIOLOGICAL

the ucMSCs suspension(3× 106 cells per kg of the patient's weight) will be instilled through a 6 French end-hole catheter inserted into the infant's endotracheal tube

Control

Normal saline

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type OTHER

the same amount of ucMSCs suspension will be instilled through a 6 French end-hole catheter inserted into the infant's endotracheal tube

Interventions

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ucMSCs

the ucMSCs suspension(3× 106 cells per kg of the patient's weight) will be instilled through a 6 French end-hole catheter inserted into the infant's endotracheal tube

Intervention Type BIOLOGICAL

Normal saline

the same amount of ucMSCs suspension will be instilled through a 6 French end-hole catheter inserted into the infant's endotracheal tube

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* severe BPD, defined by the National Institute of Child Health and Human Development workshop, who conventional therapies (including furosemide and theophylline, and HFO ventilation) has failed

Exclusion Criteria

* severe congenital anomalies
* severe intraventricular hemorrhage ≥ grade 3 or cystic periventricular leukomalacia.
Minimum Eligible Age

1 Week

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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China Medical University Hospital

Principal Investigators

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Bai-Horng Su, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

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China Medical University Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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DMR99-104

Identifier Type: -

Identifier Source: org_study_id